- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07567417
Endocrinal Dysfunction Among Children With Dilated Cardiomyopathy
Endocrinal Dysfunction Among Children With Dilated Cardiomyopathy at Sohag University Hospital
All patients in this study will be subjected to the following (as detailed in the attached patient's data sheet).
Clinical History: focusing on:
- Socio-demographic factors, especially age, gender, family history, and degree of consanguinity.
- Cardiac symptoms, such as feeding difficulties in the infant, exercise intolerance in older children, fatigue, dyspnea on exertion, heart failure symptoms.
Thorough clinical examination: focusing on:
- General condition.
- Anthropometric measures (weight, height, and body mass index).
- Vital signs (Including HR, BP, SO2, RR, Body temperature).
- Cardiac examination (including any associated murmur, signs up heart failure).
Severity of heart failure in children with dilated cardiomyopathy For all patients, they were classified according to Children's Ross HF classification.
Children's Ross HF classification is as follows[17]:
Class I: asymptomatic cases.
Class II: mild tachypnea or diaphoresis with feeding in infants, dyspnea on exertion in older children.
Class III: marked tachypnea or diaphoresis with feeding in infants, marked dyspnea on exertion, and prolonged feeding times with growth failure.
Class IV: tachypnea, retractions, grunting, or diaphoresis at rest are examples of symptoms.
- Data collection: according to attached checklist for every patient involved in the study
Studieoversikt
Status
Detaljert beskrivelse
Dilated cardiomyopathy is defined as "dilatation and impaired contraction of the left or both ventricles with normal wall thickness" . It is characterized by systolic dysfunction with reduced myocardial contractility . DCM is the third leading cause of heart failure in pediatrics 3. The exact etiology of DCM is unknown in more than half of the cases and the term idiopathic DCM is used after exclusion of all the well-known etiologies of DCM as viral infections, autoimmune, genetic, endocrinal, and metabolic diseases .
DCM is typically diagnosed when patients present with heart failure symptoms, typically related to left ventricle systolic dysfunction, but right systolic dysfunction may accompany left ventricle failure . About 8-15% of patients will present with cardiac arrest, or with near-arrest requiring emergent resuscitation. In the remainder of patients, the most common symptom is shortness of breath (50%), followed by gastrointestinal upset and fatigue that is reported in a third of patients. Symptoms of an upper respiratory tract infection are also common. Echocardiography is the gold standard for diagnosis of DCM .
Methods:
All patients in this study will be subjected to the following (as detailed in the attached patient's data sheet).
Clinical History: focusing on:
- Socio-demographic factors, especially age, gender, family history, and degree of consanguinity.
- Cardiac symptoms, such as feeding difficulties in the infant, exercise intolerance in older children, fatigue, dyspnea on exertion, heart failure symptoms.
Thorough clinical examination: focusing on:
- General condition.
- Anthropometric measures (weight, height, and body mass index).
- Vital signs (Including HR, BP, SO2, RR, Body temperature).
- Cardiac examination (including any associated murmur, signs up heart failure).
Severity of heart failure in children with dilated cardiomyopathy For all patients, they were classified according to Children's Ross HF classification.
Children's Ross HF classification is as follows[17]:
Class I: asymptomatic cases.
Class II: mild tachypnea or diaphoresis with feeding in infants, dyspnea on exertion in older children.
Class III: marked tachypnea or diaphoresis with feeding in infants, marked dyspnea on exertion, and prolonged feeding times with growth failure.
Class IV: tachypnea, retractions, grunting, or diaphoresis at rest are examples of symptoms.
- Data collection: according to attached checklist for every patient involved in the study
Investigations: focusing on
- Laboratory investigations (IGF-1, free T3 and T4, TSH, morning serum cortisol and ACTH, 25 OH vit D, total and ionized calcium, serum parathyroid hormones levels, serum prolactin, serum electrolytes as Na, K). Samples to be withdrawn from cases and controls at 9:00 a.m. at the Pediatric Cardiology Unit, Sohag University Hospital.
- Echocardiography assessment including:
Ejection fraction
Fractional shortening
Left ventricular end systolic diameter
Left ventricular end diastolic diameter
Mitral valve closure to opening time
Left ventricular ejection time
Mitral valve ejection
Mitral valve area
E/A ratio Mitral valve
Myocardial performance index of Left ventricular
- Possible Therapeutic Modalities given to patients in the study Medical treatment (e.g .Anti-failure medications: Diuretics, ACE inhibitors,..etc.)
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Nourhan Elsayed, Pediatric resident at Sohag Un
- Telefonnummer: 01122317103
- E-post: norhan.elsayed@med.sohag.edu.eg
Studiesteder
-
-
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Sohag, Egypt
- Pediatric department at Sohag University hospital
-
Ta kontakt med:
- Nourhan Elsayed
- Telefonnummer: 01122317103
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- children aged 1 to 12 years diagnosed with dilated cardiomyopathy by Echocardiography.
Control: Age and sex match children attending Pediatric cardiology clinic with acute non serious illness to be included as Control
Exclusion Criteria:
- Other types of cardiomyopathy (As hypertrophic, restrictive cardiomyopathy and other types).
Dilatation of Left ventricle due to other congenital or rheumatic heart diseases
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Case Group.
Children aged 1 to 12 years diagnosed with dilated cardiomyopathy (DCM) by Echocardiography.
|
Assessment of Ejection fraction, Fractional shortening, and LV diameters/volumes to confirm diagnosis and severity.
Blood samples will be collected at 9:00 a.m. to measure IGF-1, free T3 and T4, TSH, morning serum cortisol, ACTH, 25 OH vit D, calcium, parathyroid hormones, prolactin, and electrolytes (Na, K).
|
|
Eksperimentell: Control Group.
Age and sex matched children with acute non-serious illnesses.
|
Blood samples will be collected at 9:00 a.m. to measure IGF-1, free T3 and T4, TSH, morning serum cortisol, ACTH, 25 OH vit D, calcium, parathyroid hormones, prolactin, and electrolytes (Na, K).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Assessment of endocrine parameters in children with dilated cardiomyopathy
Tidsramme: One year
|
Insulin growth factor to be withdrawn from patient with dilated cardiomyopathy by venipuncture
|
One year
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- Soh-Med-25-10-10MS
Plan for individuelle deltakerdata (IPD)
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